US6328710B1 - Process improvements for preparing catheter balloons - Google Patents

Process improvements for preparing catheter balloons Download PDF

Info

Publication number
US6328710B1
US6328710B1 US08/955,984 US95598497A US6328710B1 US 6328710 B1 US6328710 B1 US 6328710B1 US 95598497 A US95598497 A US 95598497A US 6328710 B1 US6328710 B1 US 6328710B1
Authority
US
United States
Prior art keywords
balloon
tubing
mold
waist
balloons
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime, expires
Application number
US08/955,984
Inventor
Lixiao Wang
Paul J. Miller
Daniel J. Horn
Deborah A. Frank
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Boston Scientific Scimed Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US12423893A priority Critical
Priority to US19763494A priority
Priority to US08/650,222 priority patent/US5714110A/en
Application filed by Boston Scientific Scimed Inc filed Critical Boston Scientific Scimed Inc
Priority to US08/955,984 priority patent/US6328710B1/en
Application granted granted Critical
Publication of US6328710B1 publication Critical patent/US6328710B1/en
Assigned to BOSTON SCIENTIFIC SCIMED, INC. reassignment BOSTON SCIENTIFIC SCIMED, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: SCIMED LIFE SYSTEMS, INC.
Adjusted expiration legal-status Critical
Application status is Expired - Lifetime legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/18Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor using several blowing steps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/42Component parts, details or accessories; Auxiliary operations
    • B29C49/78Measuring, controlling or regulating
    • B29C49/783Measuring, controlling or regulating the blowing pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1075Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1088Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/0073Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor characterised by the parison configuration, e.g. nestable
    • B29C2049/0089Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor characterised by the parison configuration, e.g. nestable the parison being a tube, e.g. a tube which has to be reheated before blow moulding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/04Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould using liquids, gas or steam
    • B29C35/041Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould using liquids, gas or steam using liquids
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/02Combined blow-moulding and manufacture of the preform or the parison
    • B29C49/04Extrusion blow-moulding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00Use of polyesters or derivatives thereof, as moulding material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/25Solid
    • B29K2105/253Preform
    • B29K2105/258Tubular
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2905/00Use of metals, their alloys or their compounds, as mould material
    • B29K2905/08Transition metals
    • B29K2905/12Iron
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7542Catheters
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1328Shrinkable or shrunk [e.g., due to heat, solvent, volatile agent, restraint removal, etc.]
    • Y10T428/1331Single layer [continuous layer]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139Open-ended, self-supporting conduit, cylinder, or tube-type article

Abstract

A method for forming a balloon for a dilatation catheter may utilize the steps of extruding a tubing preform of a polyester resin and then blowing the tubing into an oriented balloon, wherein the tubing preform is dried prior to blowing into the balloon form. Other process steps by which balloon cone and waist thicknesses may be reduced involve varying the axial tension and blowing pressure at several stages as a mold containing the balloon preform is dipped into a heating medium. Specifically, tubing of a thermoplastic material is placed in a mold and blown by pressurizing and tensioning the tubing and gradually dipping the mold into a heated heat transfer media so as to sequentially blow a first waist, a body and a second waist portion. The tubing is subjected to a relatively lower pressure while the body portion is blown than while the first and second waist portions are blown.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No. 08/650,222, filed May 20, 1996, now U.S. Pat. No. 5,714,110 which is a file wrapper continuation of U.S. patent application Ser. No. 08/197,634, filed Feb. 17, 1994, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/124,238, filed Sep. 20, 1993, now abandoned.

BACKGROUND OF THE INVENTION

The present invention relates to a method for making balloons for catheters used in medical dilatation procedures.

Balloon catheters are being used extensively in procedures related to the treatment of blood vessels. For example, arterial stenosis is commonly treated by angioplasty procedures which involve inserting balloon catheters into specific arteries. Balloon catheters have also been found useful in procedures involving dilation of body cavities.

The most widely used form of angioplasty makes use of a dilatation catheter which has an inflatable balloon at its distal end. Using fluoroscopy, a physician guides the catheter through the vascular system until the balloon is positioned across the stenoses. The balloon is then inflated by supplying liquid under pressure through an inflation lumen to the balloon. The inflation of the balloon causes stretching of a blood vessel and pressing of the lesion into the blood vessel wall to reestablish acceptable blood flow through the blood vessel.

In order to treat very tight stenoses with small openings, there has been a continuing effort to reduce the profile of the catheter so that the catheter can reach and pass through the small opening of the stenoses. There has also been an effort to reduce the profile of the catheter after an initial use and deflation of the balloon to permit passage of the catheter through additional lesions that are to be treated or to allow entry and retreatment of lesions that reclose after initial treatment.

One factor manipulated to reduce the profile of the dilatation catheter is the wall thickness of the balloon material. Balloons for dilatation balloon catheters have been made from a wide variety of polymeric materials. Typically the balloon wall thicknesses have been on the order of 0.0004 to 0.003 inches for most materials. There have been continuing efforts, however, to develop ever thinner walled balloon materials, while still retaining the necessary distensibility and burst pressure rating, so as to permit lower deflated profiles.

It is possible to make balloons from a variety of materials that are generally of the thermoplastic polymeric type. Such materials may include: polyethylenes and ionomers, ethylene-butylene-styrene block copolymers blended with low molecular weight polystyrene and, optionally, polypropylene, and similar compositions substituting butadiene or isoprene in place of the ethylene and butylene; poly(vinyl chloride); polyurethanes; copolyesters; thermoplastic rubbers; silicone-polycarbonate copolymers; polyamides; and ethylene-vinyl acetate copolymers. Orientable polyesters, especially polyethylene terephthalate (PET), are among the preferred materials for forming catheter balloons.

References illustrating the materials and methods of making catheter balloons include: U.S. Pat. No. 4,413,989 and U.S. Pat. No. 4,456,000 to Schjeldahl et al, U.S. Re 32,983 and Re 33,561 to Levy, and U.S. Pat. No. 4,906,244, U.S. Pat. No. 5,108,415 and U.S. Pat. No. 5,156,612 to Pinchuck et al. The Levy patents, teach that a high tensile strength polyethylene terephthalate balloon can only be formed from a high intrinsic viscosity polymer, specifically, high molecular weight polyethylene terephthalate having a requisite intrinsic viscosity of at least 1.0.

High tensile strengths are important in angioplasty balloons because they allow for the use of high pressure in a balloon having a relatively small wall thickness. High pressure is often needed to treat some forms of stenosis. Small wall thicknesses enable the deflated balloon to remain narrow, making it easier to advance the balloon through the arterial system.

Polyesters possessing a lower intrinsic viscosity are easier to process, and hence balloon manufacturers have desired to use polyesters possessing an intrinsic viscosity below 1.0. However, it was thought that using such material would sacrifice the strength of the balloon. Recently it has been discovered that angioplasty catheter balloons, having a wall strength of greater than 30,000 psi and a burst strength of greater than 300 psi, can be prepared from a PET polymer of an intrinsic viscosity of 0.64-0.8. This, high strength, non-compliant balloon, made from a standard intrinsic viscosity polyester, has been a significant improvement in the art. There remains, however, a need to continue to improve balloon wall strengths while simultaneously reducing their wall thickness.

Prior art PET balloon forming techniques involve blowing or stretching and blowing of the balloon in a segment of extruded PET tubing. It has been recognized that control of moisture in the PET resin, prior to extrusion, is important and prior art techniques have embodied a drying step prior to extrusion of PET tubing from which the balloon is formed by stretch blow molding techniques. However it has not been previously suggested that drying of extruded tubing would provide any benefit properties of the balloons produced from the extruded tubing.

Balloons produced by stretching and blowing a tubular preform or “parison” typically have much thicker waist and cone walls than the wall thickness of their body portions. The thicker cone walls contribute to the overall thickness of the catheter, making tracking, crossing and recrossing of lesions more difficult. Further, thick cones interfere with refolding of the balloon on deflation so that the deflated balloon can only be further inserted or withdrawn with difficulty, occasionally even damaging the blood vessel.

There have been several solutions proposed for reducing the cone or waist thickness of catheter balloons in U.S. Pat. No. 4,906,241, U.S. Pat. No. 4,963,313, and EP 485,903. However, the procedures involved in these references are quite cumbersome and so it is desirable that simplified methods be developed to provide cone and waist walls with reduced thicknesses.

SUMMARY OF THE INVENTION

The present invention in one aspect is an improved method for forming a balloon for a dilatation catheter involving the steps of extruding a tubing preform of a polyester resin and then blowing the tubing into an oriented balloon, the improvement comprising that the tubing preform is dried prior to blowing into the balloon form. The addition of this novel step to the balloon forming method has been observed to cause a reduction in the frequency of balloons which are rejected because of defects in the balloon wall while producing the same or higher wall strengths in the non-defective balloons obtained.

It has also been discovered that the problem of thick balloon cones and waists can be substantially improved by varying the axial tension and blowing pressure at several stages as a mold containing the balloon preform is dipped into a heating medium. A further aspect of the invention therefore is an improved method of forming a balloon for a catheter, comprising placing tubing of a thermoplastic material in a mold and blowing the balloon by pressurizing and tensioning the tubing and gradually dipping the mold into a heated heat transfer media so as to sequentially blow the first waist, the body and the second waist portions of the balloon, the tubing being subjected to a relatively lower pressure, and preferably a relatively a lower tension, while the body portion is blown than while the first and second waist portions are blown.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an angioplasty catheter having a balloon of the invention mounted thereon.

FIGS. 2a, 2 b and 2 c illustrate the results of various process steps in forming a catheter balloon, depicting respectively, side elevational views of an extruded tube of polymer material used to form the balloon, a stretched tubing preform prepared from the extruded tube, and a formed balloon prepared from the stretched tubing preform.

FIG. 3 is a schematic view of a stretching device that may be useful in practicing the method of the invention.

FIG. 4 is a cross-sectional view of a preferred mold used in the method of the invention.

FIG. 5 is a side elevation view of a molding station that may be useful in practicing the method of the invention.

FIG. 6 is a perspective schematic representation of relevant portions of the molding station of FIG. 5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A dilatation balloon catheter of the present invention, illustrated generally at 10 in FIG. 1, includes an inflatable balloon 14 mounted at the distal end of an elongated flexible shaft 11. Catheter 10 is conventional in its construction, providing a lumen communicating with the interior of balloon 14, for inflation and deflation of the balloon, and other optional features conventional in the dilatation catheter art. The balloon 14 is in its inflated configuration. The balloon 14 is formed of a thermoplastic polymer material which provides the balloon with its essential compliance characteristics. The balloon may be noncompliant and made of stiff materials such as PET or nylon, or it may be compliant, made of polyester copolymers, blends of polyesters or blends of a polyester with a minor portion of another thermoplastic polymer which disrupts the crystallinity of the polyester. Other thermoplastic materials such as previously described for catheter balloons may be employed. Most advantageously the balloon material is a polyester, a polyamide or similar highly orientable polymer material.

The balloon of this invention, in one aspect, is obtained by extruding tubing of a thermoplastic polymer comprising a polyester, drying the tubing, suitably for at least 4 hours, and preferably at least 24 hours, and then expanding the extruded tubing axially and radially. In this drying step the tubing is suitably dried to a moisture content weight of 0.15% or less, by any suitable means, including vacuum drying with or without heat and with or without a desiccant.

Any conventional extruder may be employed to perform the extrusion process. After the resin has been extruded into tube form and dried, it preferably undergoes a prestretch which axially elongates the tubing. Referring to FIGS. 2a-2 c, the prestretching process comprises applying an axial stretching force to the extruded tubing 12, heating the extruded tubing, allowing the extruded tubing to stretch while maintaining the axial stretching force and finally cooling the stretched tubing 13. Once the prestretch is complete, the stretched tubing 13 is radially expanded into the form of a balloon 14, using a molding process. The molding process comprises placing the stretched tubing 13 in a mold, heating the mold and expanding the stretched tubing radially by means of internal pressure. After sufficient time has passed for the balloon to form, the mold is cooled and the balloon 14 is removed.

The starting resin used to produce the balloon of this invention is most preferably a PET homopolymer or copolymer. The resin should be relatively free of foreign material and other contaminants. Polyethylene terephthalate in pellet form may be employed. Suitable examples are Shell Chemical's Cleartuf 7207 and Traytuf 7357, and DuPont's Selar X260. The intrinsic viscosity of the PET resin is preferably between 0.64-0.80, more preferably between 0.68-0.76 and most preferably between 0.72-0.74. Intrinsic viscosity, which is a function of the molecular weight, may be determined by means of manufacturer standard processes, or ANSI/ASTM D 2857-70.

Well controlled processing of the PET resin is important to attaining the desired strength and compliance characteristics in the final balloon. The PET resin is preferably dried to less than 10 ppm moisture content prior to extrusion. Drying to this level prevents excessive degradation of the material during extrusion and also reduces other defects such as tubing haziness or bubbles.

Once the pellets have been sufficiently dried, they are extruded under carefully controlled conditions. As stated previously, any conventional extruder may be employed to perform the extrusion. Suitably, a Killion extruder with a 1.25 inch diameter barrier flight screw is used.

In order to obtain optimal results, the processing temperatures applied to transform the raw resin into balloon preform tubing are meticulously maintained. A preheater may be employed that permits the use of a small extruder while still maintaining normal torque levels. The preheater heats the resin to 370° F. Thereafter, the pellets move to the feedthroat which is maintained at a temperature of 140-180° F. Next, the PET material passes through three extruder zones, the first of which is preferably maintained at 490° F.(+/−5° F.) while the following two are maintained at 500° F.(+/−5° F.). The PET material then passes through a clamp and a melt filter before it reaches the die. The clamp, melt filter and two temperature zones within the die are all maintained at 500° F.(+/−5° F.). The melt filter removes foreign matter from the PET material, thereby ensuring a correct failure mode in the final balloons. Optimally, the residence time in the extruder is kept to a minimum. The preferred die size is in the range of 0.060-0.080 inches.

After the PET material extrudes out of the die in tube form, it must be cooled. One way to perform the cooling process is to pass the extruded tubing from the extruder, through a small air gap and into a water bath maintained at approximately 60-70° F. A puller may be used to pull the tube from the cooled end through the water bath. Thereafter, the tubing is cut into lengths. The area draw down ratio of the extruded tubing (which is the area defined by the die and mandrel divided by the cross-sectional area of the extruded tubing) should be less than 10.

After the tubing has been extruded and cut, it is preferably prestretched to axially elongate the tubing prior to its radial expansion. In the past it was considered important to prestretch and mold the balloon soon after the tube had been extruded, to reduce the chance that the tube would not be degraded by atmospheric moisture. Immediate prestretching and blowing is sometimes inefficient in a commercial manufacturing operation, however, and was not a fully reliable method of assuring a uniform yield of high quality balloons. It has now been discovered that the negative effects of exposure to atmospheric moisture can readily be avoided or reversed by desiccating the extruded tubing, preferably to a moisture content of no more than 0.15 weight %. In accordance with one aspect of the invention, therefore, the preform is dried between the extrusion and blowing steps, suitably between extrusion and prestretching. Drying may be accomplished by heating the extruded tubing at 50° C.-60° C. in a vacuum oven, suitably at a pressure of 10−6 atm or less; or in a desiccator containing a conventional desiccant suitably at a pressure of 600-760 mm Hg, at ambient temperature. The tubing is dried for a period of at least 4 hours, preferably 24 more hours, preferably at least 48 hours, or until a sample preform of a batch introduced simultaneously into the desiccator is measured to have a moisture content of no more than 0.15%, preferably less than 0.10%, more preferably less than 0.075%, water. Examples of suitable desiccants which may be employed to aid in drying the tubing include silica gel, molecular sieves, for instance molecular sieves 3A and 4A, calcium chloride, phosphorus pentoxide, and Drierite. A combination of heat, vacuum and desiccant may be used to obtain the necessary dryness in a shorter period of time if desired.

The prestretch step stretches a section of a cut length of tubing to a predetermined length by applying an axial stretching force to the tube while the tube is heated. Once the tube is exposed to the higher temperature, the axial stretching force is maintained and the tubing is stretched at a specific rate. Desirably, the tube is heated just prior to stretching.

FIG. 3 illustrates one device useful in performing the prestretch. The device 18 of FIG. 3 possesses two jaws 20 and 22 capable of gripping at least one cut length of extruded tubing 12. The stretching device 18 lowers the tubing 12 into a bath 24 containing heated media maintained at a temperature above the glass transition temperature of the extruded tubing 12. A suitable temperature is the range extending from 85-95° C. However, the preferred media is water at a temperature of 90° C.(+/−2° C.). The first gripping jaw 20 may remain stationary while the second gripping jaw 22 moves horizontally at a set rate to a predetermined final position, thereby achieving the desired final stretch. The preferred rate of stretching is 25% per second. The desired amount of axial elongation prior to radial expansion is in the range of 75-150%. Preferably, however, the axial elongation occurring in this phase is 125%. Therefore, the stretch ratio, calculated by dividing the final length of the stretched section of tubing (the portion between jaws 20 and 22) by the initial length of that section, is 2.25.

After the tubing 12 is stretched to the desired stretch ratio and length, it is cooled. This may be accomplished with a device such as the device 18 of FIG. 3 by controlling the jaws 20 and 22 such that they finish stretching the tubing 12 and automatically lift up out of the bath 24. The stretched tubing 13 may then be moved to a cooling water bath (not shown), preferably maintained at room temperature. During this cooling process, the stretched tubing portion 13 of tubing 12 is held on both ends in order to apply sufficient tension to ensure that the tube does not relax and shrink or recover from the stretch.

After cooling, the stretched tubing 13 is removed from the water bath and expanded radially using internal pressure. The dimensions to which it is stretched are preferably controlled by performing the radial stretching while the tubing 13 is in a mold having the shape of the desired balloon. A suitable mold 28 is shown in FIG. 4. Heating the stretched tubing 13 while radially expanding it may best be accomplished by dipping the mold 28 into hot water while internal pressure is applied.

To perform the radial expansion step one end of the stretched tube inside of the area where it was gripped by jaws 20 and 22 is cut off to provide an opening to the lumen of the tubing 13. The stretched tube 13 then fed through the mold 28 which consists of three parts: the proximal portion (top) 30, the body 40 and the distal (bottom) portion 50. These three sections fit tightly together and provide the tubing 13 a form to blow to.

Referring to FIG. 4, the distal portion 50 of the preferred mold 28 is generally between 0.6 and 1.4 inches long, which includes the enlarged end section 51 used to hold the mold 28 in the molding fixture 62 (FIG. 5). The distal cone section 52 is formed at an angle of between 15° and 45° with the axis of the mold 28. The cup 54 of the distal portion, which interfaces with the distal insert portion 42 of body 40, generally has a length of 0.120 inches. The proximal portion 30 of the preferred mold 28 is generally between 1.1 and 2.0 inches long. The proximal cone section 32 is also formed at an angle of between 15° and 45° with the axis of the mold 28. The cup 34 of the proximal portion interfaces with the proximal insert portion 44, symmetrical with the distal insert mold portion 42 of body 40. The length for the balloon body 40 is generally between 0.4 and 2 inches long. The inner and outer diameter of the mold sections 30, 40 and 50, and the angles of each cone 32, 52 are both dependent on the desired balloon size. The mold 28 for the balloon will be different when producing different sized balloons, which is necessary to meet the preference or needs of those who will perform medical treatments with the balloon.

The molds 28 of the present invention are preferably made of 303 stainless steel with a smooth mirror finish to provide a smooth finish on the balloon surface. The surface roughness average should be in the range of 5-10 microns or less.

The appropriate mold 28, with the stretched tubing 13 inside, may be heated while pressure is applied using a device 60 such as the one depicted in FIGS. 5 and 6. With this device 60, the mold 28 is placed in a holder 62. The tubing 13 extends out from the top of the mold 28 and is fed into a Touhy clamp 64 through which a pressurized fluid, preferably nitrogen gas, is applied to the inner lumen of the tubing 13. The tubing at the bottom of the mold 28 is clamped off such that no gas can flow through it. The pressure applied is suitably in the range of 210-280 psi.

One advantage of using a device 60 is that tension may be applied to the tubing 13 during the molding phase. A string 65 trained over pulley 66 (shown in FIG. 6 but deleted from FIG. 5 for sake of clarity) may be attached to a tension clamp 67 adjacent the Touhy clamp 64. The tension clamp 67 holds the tubing 13 to apply tension to it without closing off the flow path of pressurized fluid into tubing 13. Weights 68 attached to the end of string 65 may thus provide tension to the tubing 13. Generally, 0-500 g of tension may be applied. Tension may be applied during the molding process to better control the wall thickness of certain areas of the balloon, primarily the waist sections. The tension decreases the cross sectional area of the balloon waists, thereby increasing flexibility in those regions.

The tubing 13, subjected to specific interior pressures, is then heated. As depicted by dashed lines in FIG. 5, the mold 28 is dipped into a water bath 70, suitably at a rate of 4 mm/sec., with the total process of submerging the mold 2.3 inches into the bath 70 taking approximately 15 seconds. Preferably, the bath 70 is a hot water bath maintained at a temperature range of 85-98° C., with 95° C.(+/−1° C.) being the most preferred temperature. Once the entire mold 28 has been submerged it is held stationery for a period of time, suitably 40 seconds, while the balloon and waist portions yield completely and stabilize. The radial expansion, or hoop ratio (calculated by dividing the inner diameter of the balloon by the inner diameter of the extruded tubing), should be in the range of 6-8.5. However, the preferred hoop ratio is approximately 8.0. A lower hoop ratio may result in compliance which is higher than desired. A higher hoop ratio may result in preforms which will not blow out fully. During this phase of radial expansion, the tubing 13 will further elongate, i.e. expand further in the axial direction, such that the total elongation of the tubing 13 in the finished balloon body will range from 175-275% of the length of the unstretched tubing used to form the body of the balloon.

In accordance with a further aspect of the invention the stretched tubing 13 is blown during a programmed dipping cycle, for dipping into hot water bath 70, during which the pressure and axial tension are varied at several stages so that the balloon is sequentially blown from one end to the other (proximal, body and distal, or vice versa). By this method, a reduced waist and cone thickness is obtained without the necessity of introducing a separate processing operation directed specifically to cone and waist reduction.

FIG. 4 has been labeled to show depth regions at which transitions of pressure and/or tension occur in this aspect of the invention as mold 28 is dipped into bath 70. Corresponding locations on the balloon 14 are labeled in FIG. 1. The region B-C comprises the proximal waist portion, the region C-D comprises the proximal cone portion, the region D-E comprises the body portion, the region E-F comprises the distal cone portion and the region F-G comprises the distal waist portion of the mold. The balloon blowing process of the invention involves the steps of:

pressurizing the stretched tubing to a first pressure in the range of 150-320 psi and applying a first tension in the range of 5-150 g;

dipping the mold to a first depth in the range of from the transition (C) from the first waist to the first cone to the transition (D) from the first cone to the body portion of the balloon;

reducing the pressure to a second pressure between 80 and 170 psi and setting a second tension in the range of the first tension;

dipping the mold to a second depth in the range of from the transition (E) from the body portion to the second cone portion to the transition (F) from the second cone to the second waist;

increasing the pressure to a third pressure higher than the second pressure and between 150 and 320 psi and increasing the tension to a third tension, higher than the first and second tensions, and then,

dipping the mold to a third depth (H) beyond the depth (G) of the second waist.

Although the process may be accomplished with substantially continuous dipping, it is preferred that the mold be held at each of the first, second and third depths for predetermined time intervals before changing pressure/tension parameters and moving to the next depth. Suitable hold time intervals are between 1 and 40 seconds at the first depth, between 1 and 40 seconds at the second depth and between 10 and 100 seconds at the third depth. A typical dipping program for a PET polymer balloon, beginning at an initial depth (A) before the depth (B) of the first waist of the balloon, and using a 95° C. hot water bath as heating media, will take a total of approximately 60-90 seconds. Typical programs for PET balloons are illustrated in Examples 4-9.

The third tension is suitably in the range of 50 to 700 g, and is higher than the second tension, suitably higher than both the first and second tensions. For balloons of 4.00 mm diameter or less, the third tension will usually not exceed 500 g. The second tension may be the same or different from the first tension and if different will usually be less than the first tension. In general the tension employed at all depths will be higher as the diameter of the balloon is increased. For balloons having nominal diameters of at least 2.25 mm it is preferred that the third tension be higher than both the first and second tensions by at least 150 grams and at all typical angioplasty balloon diameters it is preferred that the difference between the second and third pressures be at least 100 psi, usually at least 150 psi.

It should be noted that this aspect of the invention can also be practiced by inserting the end of mold 28 which forms the distal end of the balloon into the heating bath first.

The balloon formed in the mold is next cooled. One way to cool the balloon is to remove the mold 28 from the hot water bath 70 and place it in a cooling bath 72. As shown in FIG. 5, this step may be accomplished through use of a machine 60 having a pivot arm 74 capable of transferring the mold 28 from the hot 70 to the cold water bath 72. The cooling bath 72 is preferably maintained at 7-15° C. In the preferred embodiment, the balloon remains in the cooling bath 72 for approximately 10 seconds.

Finally, the ends of the tubing 13 extending from the mold 28 are cut off and the balloon is removed from the mold 28 by removing either the distal end 50 or proximal end 30 from the body section 40 of mold 28, then gently pulling the balloon from the remaining mold sections. To mount on a catheter 10, balloon 14 is cut at B and G and adhered to the catheter in conventional manner.

The various aspects of the invention are illustrated by the following non-limiting examples. In the examples wall thickness measurements are single wall thicknesses unless specifically specified as double wall thicknesses.

EXAMPLE 1 (Post Extrusion Drying)

The product of this example is a 3.00 mm balloon. Shell Chemical Cleartuf 7207 PET pellets, reported as having an intrinsic viscosity of 0.73 as determined by Goodyear R100E intrinsic viscosity test method, were dried to approximately 10 ppm moisture content. The dried resin was extruded into tubing and cut into 8 inch sections. The tubing sections had an OD of 0.0425 in. and an ID of 0.0183 in.

The extruded tubing sections were next stretched to a predetermined length by applying an axial stretching force to the individual tubing sections and heating them. Each tubing section was placed in an automated prestretching device possessing two gripping mechanisms capable of concurrent vertical motion. The prestretching device lowered the tubing section into a deionized water bath 24 heated to 90° C.(±2° C.). One of the two gripping mechanisms remained stationary while the other moved horizontally at a rate of 25%/sec. for 5 seconds. The resulting axial elongation, due to the 2.25 stretch ratio, was approximately 125%.

After the prestretch was complete, the tubing section was manually removed from the pre-stretching device and cooled for a few seconds in a deionized water bath maintained at room temperature. The tubing section was held in order to apply sufficient tension to ensure that the tube 12 did not recover from the stretch. The stretched tubing section was then removed from the water bath.

After cooling, the stretched tubing section was expanded radially using internal pressure. One end of the stretched tube was cut to provide an opening to the lumen of the tubing. In order to form a 3.75 mm balloon with a 20 mm body length, a mold having dimensions that allowed the stretched tube to blow out to the appropriate body size and balloon waist inner diameters was used.

After the tubing section was securely inside the mold, the mold was placed in a holder. The tubing section extended out the top of the mold and was fed into a Touhy clamp through which nitrogen gas was applied to the inner lumen of the tubing at 260 psi. No tension was applied to the tubing. The tubing section at the bottom of the mold was clamped off such that the pressure was maintained inside the tubing section. The mold was then gradually dipped, at a rate of 4 mm/sec., into a deionized hot water bath maintained at 95° C.(±1° C.) to a point just above the proximal waist portion of the mold. The entire dipping process consumed 15 sec. and the mold was held stationary in the bath 70 for 40 sec. Then the mold was removed from the hot water bath and cooled for approximately 10 sec. in a deionized water bath maintained at about 11° C. The balloon axially expanded during the molding by an additional 50% of its original tubing length, resulting in a total axial elongation of 175%.

Thirty balloons prepared in this manner from a single lot of tubing were used as controls.

Balloons of the invention were made in the same manner from the same lot of tubing as the controls except that the prior to the prestretching step, the tubing sections were dried in a vacuum desiccator. Five marked and preweighed tubes were used to monitor weight loss after 24 and 48 hour desiccation intervals. After 24 hours the balloons had lost an average of 0.38% of their undesignated weight. After 48 hours the average weight loss was 0.44%.

Meanwhile, in the same desiccator, 80 unmarked tubes were dried. After 24 hours 30 tubes were removed and processed into balloons in the manner of the controls. An additional 30 balloons were made from tubes which were kept in the desiccator for 48 hours.

All balloons were inspected for “bubble” defects and observed defects were categorized as small (<0.004 inch dia.), medium (0.004-0.01 inch) and large (>0.01 inch). “Bubble” defects are typically tear shaped or American football shaped visible distortions which are sometimes, but not always, hollow. Results were as follows:

Controls: 18“bubbles”. 1 Large, 7 medium, 10 small. Four balloons had more than one “bubble”.

24 hours: 11 “bubbles”. 0 Large, 1 medium, 10 small. No balloons with more than one “bubble”.

48 hours: 7 “bubbles”. 0 Large, 3 medium, 4 small. No balloons with more than one “bubble”.

Six balloons from each batch which displayed no defects were then subjected to standard burst tests by measuring the double wall thickness of the deflated balloon, inflating the balloon at incrementally increasing pressures and measuring the outside diameter at each increment until the balloon burst. Typical and average results for each batch are given in Table 1 where Dnom is diameter at nominal inflation (118 psi), Pburst and Dburst are, respectively, average burst pressure and average burst diameter.

TABLE 1 0 Hours 24 Hours 48 Hours Single wall thickness 0.00062″ 0.00067″ 0.00068″ Pressure (psi) Measured body diameter (mm) 40 3.65 3.66 3.66 88 3.75 3.75 3.75 Dnom 118 3.79 3.78 3.78 132 3.80 3.79 3.79 147 3.82 3.80 3.80 180 3.84 3.83 3.82 206 3.86 3.84 3.84 235 3.89 3.86 3.86 260 3.92 3.88 3.87 270 3.95 3.90 3.88 280 3.98 3.92 3.90 290 4.01 3.93 3.92 300 4.05 3.95 3.93 310 4.10 3.98 3.96 320 4.14 4.00 3.99 330 4.21 4.04 4.02 340 4.07 4.05 350 4.10 4.10 360 4.11 4.13 370 4.18 Average Results Pburst 323 352 353 Dburst 4.13 4.11 4.09 Distention dnom- 280 5.0% 3.7% 3.2%

EXAMPLE 2 (Post Extrusion Drying)

The procedures of example 1 were repeated. Average weight loss on desiccation for 24 hours was 0.34% and for 48 hours was 0.52%. Results of defect inspections were as follows:

Controls: 12 “bubbles”. 3 Large, 5 medium, 4 small. Three balloons had more than one “bubble”.

24 hours: 9 “bubbles”. 0 Large, 4 medium, 5 small. No balloons with more than one “bubble”.

48 hours: 5 “bubbles”. 0 Large, 3 medium, 2 small. No balloons with more than one “bubble”.

Typical and average results of burst testing are shown in Table 2:

TABLE 2 0 Hours 24 Hours 48 Hours Single wall thickness 0.00062″ 0.00067″ 0.00068″ Pressure (psi) Measured body diameter (mm) 40 3.65 3.67 3.65 88 3.76 3.75 3.76 Dnom 118 3.79 3.78 3.79 132 3.81 3.79 3.80 147 3.82 3.80 3.81 180 3.85 3.82 3.83 206 3.87 3.84 3.85 235 3.90 3.86 3.87 260 3.94 3.88 3.89 270 3.97 3.90 3.91 280 4.01 3.91 3.92 290 4.04 3.93 3.94 300 4.08 3.95 3.96 310 4.13 3.98 3.98 320 4.15 4.01 4.01 330 4.05 4.04 340 4.09 4.07 350 4.13 4.10 360 4.12 Average Results Pburst 318 349 350 Dburst 4.13 4.12 4.12 Distention dnom- 280 5.6% 3.4% 3.5%

EXAMPLE 3 (Post Extrusion Drying)

Four lots of balloons (25 in each lot) were stretched and blown from extruded PET tubing at a mold pressure of 180 psi. The molds were for 4.0 mm balloons. Mold dimensions were: length 100 mm; proximal ID 0.421″; distal ID 0.0315″; body ID 0.1600″. The tubing lots were subjected to the following conditions before stretching and blowing:

A Tubing allowed to equilibrate in a dry room to a moisture content of 0.3%. The stretch ratio before blowing was 2.15.

B Tubing vacuum dried to moisture content of 0.05% in a desiccator prior to stretching. The stretch ratio prior to blowing was 2.15.

C Tubing allowed to equilibrate in a dry room to a moisture content of 0.3%. The stretch ratio before blowing was 2.25.

D Tubing vacuum dried to moisture content of 0.05% in a desiccator prior to stretching. The stretch ratio prior to blowing was 2.25.

In blowing each lot of stretched tubing a tension was selected to assure an axial lengthening (growth) of 17-22 mm during the blowing stage and to keep the double body wall thickness between 0.00095″ and 0.00125″. All balloons were inspected for “bubbles” and foreign materials. Ten of the best balloons from each lot were burst tested and distal and proximal waists were measured on one balloon from each lot. Blowing conditions and test results are shown in Table 3.

TABLE 3 A B C D Comparative Invention Comparative Invention Pressure (psi) 180 180 180 180 Tension 133 161 137 152 Average growth 19.7 18.9 19.2 17.5 (mm) Body double wall 0.00110 0.00116 0.00108 0.00116 thickness (in) Small “bubbles” 3 0 2 0 (<0.010 mm) Medium “bubbles” 1 0 0 0 (0.004-0.10 mm) Large “bubbles” 0 0 2 0 (>0.010 mm) Burst diameter 4.3 4.3 4.3 4.3 (mm) Burst pressure (psi) 328 336 327 337 Distal wall thickness 0.0037 0.0037 0.0034 0.0041 Proximal wall 0.0023 0.0027 0.0028 0.0026 thickness

EXAMPLE 4 (Programmed Dip Cycle)

Balloons were made in a manner similar to Examples 1 and 2 except that a programmed dip cycle was used and the device of FIG. 6 was modified by replacing the pulley 66 and weight 68 with a metal cylinder containing a pressure driven piston. String 65 was attached to the piston rod so that tension could be varied by changing the pressure in the cylinder so as to move the cylinder up or down. The program was as follows, where pressures applied to the cylinder have been converted to equivalent tensions applied to the tubing.

Mold specification: Proximal waist ID 0.0352 inches Body ID 0.1195 inches Distal waist ID 0.0280 inches Cone angle 15° Prestretch stretch ratio: 2.25 Program: bath at 95° C. (1) pressure to 295 psi tension to 60 g hold at A 5 seconds dip to D 5 seconds hold at D 5 seconds (2) pressure to 120 psi tension to 60 g dip to F 10 sec hold at F 5 seconds (3) pressure to 295 psi tension to 200 g dip to G 1 sec hold at G 1 sec dip to H 10 sec hold at H 25 seconds

Average wall thickness of the balloons produced in this way were: body single wall, 0.00045 inches; proximal wall, 0.00141 inches; distal wall, 0.00169 inches.

In the remaining examples the modified version of the device of FIG. 6 which is described in the previous example was employed and a simplified programmed dipping and blowing cycle was used. In this program the mold was dipped from the initial position, A in FIG. 4, to a first depth approximately at the midpoint of the first cone i.e. midway between C and D, held and then after reducing the pressure, dipped to a second depth approximately at the midpoint of the second cone, i.e. between E and F, held and then after increasing pressure and tension, dipped to the final position H, slowing down near the final position, and then holding for a third interval before being removed and dipped in the cooling bath.

EXAMPLE 5 (Programmed Dip Cycle)

2.5 mm balloons were made from 0.0125″×0.0272″ PET extruded tubes. The extruded tubes were stretched 2.25 times of the original length at 90° C. The stretched tubes were then blown into balloons at 95° C. The mold pressure was 250 psi at proximal end, 130 psi at body, 290 psi at distal end. The pulling tension was 25 grams at proximal end and body, 180 grams at distal end. The dip cycle was 5 seconds hold at initial position, 5 sec. dip to first depth, 5 sec hold at first depth; 10 seconds dip to second position, 8 seconds hold at second position, 6 seconds to dip to the final position, holding for 30 seconds before removing and quenching in a cooling bath. The balloon has a body wall (single wall) of 0.00039″, proximal waist wall of 0.0010″, distal waist wall of 0.0012″, pressure burst at 343 psi. The compliance at 118-279 psi is less than 7%. The result is shown in Table 4.

EXAMPLE 6 (Programmed Dip Cycle)

3.0 mm balloons were made from 0.0149×0.0311 PET tube. Stretching and blowing temperatures were the same as example 1. The mold pressure was 280 psi at proximal end, 130 psi at body, 290 psi at distal end. The pulling tension was 50 grams at proximal end and 35 grams at body, 250 grams at distal end. The dip cycle was as in Example 5. The balloon has a body wall of 0.00040″, proximal waist wall of 0.0010″, distal waist wall of 0.0011″, pressure burst at 320 psi. The compliance at 118-279 psi was less than 7%. The result is shown in Table 4.

EXAMPLE 7 (Programmed Dip Cycle)

4.0 mm balloons were made from 0.0195×0.0395″ PET tube. Stretching and blowing temperatures were the same as example 1. The mold pressure was 280 psi at proximal end, 130 psi at body, 290 psi at distal end. The pulling tension was 90 grams at proximal end and 90 grams at body, 350 grams at distal end. The dip cycle was as in Example 5. The balloon has a body wall of 0.00046″, proximal waist wall of 0.0022″, distal waist wall of 0.0023″, pressure burst at 295 psi. The compliance at 118-279 psi was less than 7%. The result is shown in Table 4.

TABLE 4 Comparative Invention Balloon* Balloon % Reduction Size: 2.5 mm Balloon wall/inch .00056″ .00039″ 30 Distal waist wall .0031″ .0012″ 61 Prox. waist wall .0028″ .0010″ 64 Profile reduced** .0038″ Size: 3.0 mm Balloon wall/inch .00056″ .00040″ 29 Distal waist wall/inch .0041″ .0010″ 76 Prox. waist wall/inch .0035″ .001l″ 69 Profile reduced .0062″ Size: 4.0 mm Balloon wall/inch .00062 .00046″ 26 Distal waist wall/inch .0051″ .0023 55 Prox. waist wall/inch .0049″ .0022″ 55 Profile reduced .0056″ *Comparative balloons were commercial balloons of comparable body diameter and body wall thickness employed on NC-Shadow ™ catheters sold by SciMed Life Systems Inc., Maple Grove MN, USA and prepared by a proccss using constant pressure and tension. **Profile reduced is calculated from distal waist wall thicknesses of the comparative balloons.

EXAMPLE 8

Balloons as prepared in example 6 were mounted on catheters of comparable configuration to the NC-Shadow™ catheter of the same balloon body dimension and the resulting catheters were compared for recrossing force, pulling force, trackability and surface friendship. Recrossing force is the force to push a deflated balloon through a 0.049 inch lesion after the balloon has been inflated to 12 atm. for 1 min. Pulling force is the force to pull a deflated balloon catheter back through a 7F guide catheter after balloons were inflated to 12 atm for 1 min. All of the measurements were done at 37° C. Results are provided in table 5.

TABLE 5 Comparative catheter Invention catheter % Reduction Recrossing Force 0.29 0.16 45 (lb) Pulling force 0.13 0.10 23 from guide (lb) Trackability greatly improved Surface friendship rough good

EXAMPLE 9 (Programmed Dip Cycle)

3.0 mm balloons were made from 0.0149×0.0307″ PET tube. The tubes were dried up to 100 ppm moisture (in the range of 10-200 ppm) before stretching and blowing. The tube was stretched 2.15 times of the original length at 90° C. The stretched tube was then blown into balloon at 95° C. The mold pressure was 270 psi at proximal end, 110 psi at body, 270 psi at distal end. The pulling tension was 22 grams at proximal end and body, 50 grams at distal end. The dip cycle was as in Example 5. The balloon has a body wall of 0.00040″, proximal waist wall of 0.0013″, distal waist wall of 0.0013″, pressure burst at 330 psi. The compliance at 118-279 psi was less than 7%.

EXAMPLE 10 (Programmed Dip Cycle)

3.0 mm polyethylene copolymer balloons were made from tubing having an OD of 0.032″ and an ID of 0.0215″. The tubes were not stretched before blowing. The tubes were treated with E-beams to crosslink the polymer material. The blowing temperature was 90° C. Mold pressure was 120 psi at both ends, 80 psi at body. Pulling tension was 500 grams at the second end, 0 grams at body. Balloon wall thickness of 0.0250″-0.0275″ and burst pressure of 188 psi were the same as those with fixed pressure and without tension. However, the waist walls of the second ends of the resulting balloons were reduced 10-30%.

Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims (2)

What is claimed is:
1. A balloon for a catheter, the balloon having a first waist portion, a body portion and a second waist portion, made from the method comprising the steps:
placing tubing of a thermoplastic material in a mold and blowing the balloon by pressurizing and tensioning the tubing while gradually dipping the mold into a heated heat transfer media so as to sequentially blow the first waist, the body and the second waist portions of the balloon, the tubing being subjected to a relatively lower pressure while the body portion is blown than while the first and second waist portions are blown.
2. A catheter comprising an elongated flexible tube having a distal end with a balloon mounted thereon wherein the balloon is a balloon as in claim 1.
US08/955,984 1993-09-20 1997-10-22 Process improvements for preparing catheter balloons Expired - Lifetime US6328710B1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US12423893A true 1993-09-20 1993-09-20
US19763494A true 1994-02-17 1994-02-17
US08/650,222 US5714110A (en) 1993-09-20 1996-05-20 Process improvements for preparing catheter balloons
US08/955,984 US6328710B1 (en) 1993-09-20 1997-10-22 Process improvements for preparing catheter balloons

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US08/955,984 US6328710B1 (en) 1993-09-20 1997-10-22 Process improvements for preparing catheter balloons

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US08/650,222 Division US5714110A (en) 1993-09-20 1996-05-20 Process improvements for preparing catheter balloons

Publications (1)

Publication Number Publication Date
US6328710B1 true US6328710B1 (en) 2001-12-11

Family

ID=22730157

Family Applications (3)

Application Number Title Priority Date Filing Date
US08/650,222 Expired - Lifetime US5714110A (en) 1993-09-20 1996-05-20 Process improvements for preparing catheter balloons
US08/955,984 Expired - Lifetime US6328710B1 (en) 1993-09-20 1997-10-22 Process improvements for preparing catheter balloons
US09/016,770 Abandoned US20020110657A1 (en) 1993-09-20 1998-01-30 Process improvements for preparing catheter balllons

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US08/650,222 Expired - Lifetime US5714110A (en) 1993-09-20 1996-05-20 Process improvements for preparing catheter balloons

Family Applications After (1)

Application Number Title Priority Date Filing Date
US09/016,770 Abandoned US20020110657A1 (en) 1993-09-20 1998-01-30 Process improvements for preparing catheter balllons

Country Status (5)

Country Link
US (3) US5714110A (en)
JP (1) JP3523876B2 (en)
CA (1) CA2160487C (en)
DE (2) DE4480681C2 (en)
WO (1) WO1995022367A1 (en)

Cited By (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040036196A1 (en) * 2002-08-20 2004-02-26 Kimberly-Clark Worldwide, Inc. Powder-free nitrile gloves
US20040073165A1 (en) * 2002-10-15 2004-04-15 Scimed Life Systems, Inc. Controlled deployment balloon
US20040073250A1 (en) * 2002-10-15 2004-04-15 Pederson Gary John Catheter balloon with advantageous cone design
US20040213933A1 (en) * 2003-04-22 2004-10-28 Medtronic Ave, Inc. Low profile dilatation balloon
US20050008806A1 (en) * 2003-07-10 2005-01-13 Scott Schewe Medical device tubing with discrete orientation regions
US6863856B1 (en) 2002-12-30 2005-03-08 Advanced Cardiovascular Systems, Inc. Slotted mold for making a catheter balloon
US20050098914A1 (en) * 2003-08-18 2005-05-12 Ashish Varma Process for producing a hyper-elastic, high strength dilatation balloon made from multi-block copolymers
US20050127561A1 (en) * 2003-12-16 2005-06-16 Scimed Life Systems, Inc. Method of making expandable-collapsible bodies by temperature gradient expansion molding
US20050137619A1 (en) * 2003-12-19 2005-06-23 Scott Schewe Molds and related methods and articles
US20050146085A1 (en) * 2004-01-07 2005-07-07 Scimed Life Systems, Inc. Process and apparatus for forming medical device balloons
US20050233025A1 (en) * 2004-04-19 2005-10-20 Scimed Life Systems, Inc. Catheter balloon mold form and molding process
US20060129179A1 (en) * 2004-12-13 2006-06-15 Jan Weber Medical devices formed with a sacrificial structure and processes of forming the same
US20060134357A1 (en) * 2004-12-16 2006-06-22 Medtronic Vascular, Inc. Polymer blends for medical balloons
US20070106216A1 (en) * 2005-11-01 2007-05-10 Boston Scientific Scimed, Inc. Composite balloon
US20070142772A1 (en) * 2005-12-16 2007-06-21 Medtronic Vascular, Inc. Dual-Layer Medical Balloon
US7306616B2 (en) 2003-05-05 2007-12-11 Boston Scientific Scimed, Inc. Balloon catheter and method of making same
US20100272774A1 (en) * 2009-04-28 2010-10-28 Surmodics, Inc. Devices and methods for delivery of bioactive agents
US8025637B2 (en) 2003-07-18 2011-09-27 Boston Scientific Scimed, Inc. Medical balloons and processes for preparing same
WO2011143237A1 (en) 2010-05-10 2011-11-17 Surmodics, Inc. Glycerol ester active agent delivery systems and methods
WO2012003293A1 (en) 2010-06-30 2012-01-05 Surmodics, Inc. Lipid coating for medical devices delivering bioactive agent
US8172793B2 (en) 2000-10-31 2012-05-08 Cook Medical Technologies Llc Coated medical device
WO2012092421A2 (en) 2010-12-30 2012-07-05 Surmodics, Inc. Composition for intravascular delivery of therapeutic composition
WO2012096787A1 (en) 2010-12-30 2012-07-19 Surmodics, Inc. Double wall catheter for delivering therapeutic agent
US8413659B2 (en) 2006-09-29 2013-04-09 Covidien Lp Self-sizing adjustable endotracheal tube
US8590534B2 (en) 2009-06-22 2013-11-26 Covidien Lp Cuff for use with medical tubing and method and apparatus for making the same
EP2689789A1 (en) 2008-03-28 2014-01-29 SurModics, Inc. Insertable medical devices having microparticulate-associated elastic substrates and methods for drug delivery
US8807136B2 (en) 2006-09-29 2014-08-19 Covidien Lp Self-sizing adjustable endotracheal tube
US8813750B2 (en) 2006-09-29 2014-08-26 Covidien Lp Self-sizing adjustable endotracheal tube
WO2014186729A1 (en) 2013-05-16 2014-11-20 Surmodics, Inc. Compositions and methods for delivery of hydrophobic active agents
US9370647B2 (en) 2011-07-14 2016-06-21 W. L. Gore & Associates, Inc. Expandable medical devices
WO2016123480A1 (en) 2015-01-29 2016-08-04 Surmodics, Inc. Delivery of hydrophobic active agent particles
US9555119B2 (en) 2012-11-05 2017-01-31 Surmodics, Inc. Composition and method for delivery of hydrophobic active agents
US9757497B2 (en) 2011-05-20 2017-09-12 Surmodics, Inc. Delivery of coated hydrophobic active agent particles
US9861727B2 (en) 2011-05-20 2018-01-09 Surmodics, Inc. Delivery of hydrophobic active agent particles
WO2018112196A1 (en) 2016-12-16 2018-06-21 Surmodics, Inc. Hydrophobic active agent particle coatings and methods for treatment
WO2018118671A1 (en) 2016-12-20 2018-06-28 Surmodics, Inc. Delivery of hydrophobic active agents from hydrophilic polyether block amide copolymer surfaces
US10213529B2 (en) 2011-05-20 2019-02-26 Surmodics, Inc. Delivery of coated hydrophobic active agent particles

Families Citing this family (86)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6719773B1 (en) 1998-06-01 2004-04-13 Kyphon Inc. Expandable structures for deployment in interior body regions
US5951941A (en) * 1994-03-02 1999-09-14 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US7163522B1 (en) 1994-03-02 2007-01-16 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US6406457B1 (en) 1994-03-02 2002-06-18 Scimed Life Systems, Inc. Block copolymer elastomer catheter balloons
US7108826B2 (en) * 1994-03-02 2006-09-19 Boston Scientific Scimed, Inc. High compliance, high strength catheter balloons useful for treatment of gastrointestinal lesions
DE69611378T2 (en) * 1995-11-08 2001-04-26 Scimed Life Systems Inc necking process for balloon manufacture by cold drawing /
US6124007A (en) 1996-03-06 2000-09-26 Scimed Life Systems Inc Laminate catheter balloons with additive burst strength and methods for preparation of same
US6123712A (en) 1996-08-23 2000-09-26 Scimed Life Systems, Inc. Balloon catheter with stent securement means
US6391032B2 (en) 1996-08-23 2002-05-21 Scimed Life Systems, Inc. Stent delivery system having stent securement means
US6077273A (en) 1996-08-23 2000-06-20 Scimed Life Systems, Inc. Catheter support for stent delivery
US6358227B1 (en) 1997-09-10 2002-03-19 Scimed Life Systems, Inc. Dilatation catheter balloon made from pen based homopolymer or random copolymer
US6048338A (en) 1997-10-15 2000-04-11 Scimed Life Systems, Inc. Catheter with spiral cut transition member
US5948345A (en) * 1998-01-05 1999-09-07 Medtronic, Inc. Method for making medical balloon catheter
US6193738B1 (en) 1998-05-11 2001-02-27 Scimed Life Systems, Inc. Balloon cones and waists thinning methodology
US6024752A (en) * 1998-05-11 2000-02-15 Scimed Life Systems, Inc. Soft flexible tipped balloon
ES2354492T3 (en) 1998-06-01 2011-03-15 Kyphon Sarl Preformed structures expandable for deployment in internal body regions.
US6287506B1 (en) * 1998-07-09 2001-09-11 Schneider (Usa) Inc. Method for reducing dilation balloon cone stiffness
US6375637B1 (en) 1999-08-27 2002-04-23 Gore Enterprise Holdings, Inc. Catheter balloon having a controlled failure mechanism
US6592550B1 (en) 1999-09-17 2003-07-15 Cook Incorporated Medical device including improved expandable balloon
US6881209B2 (en) * 2000-05-25 2005-04-19 Cook Incorporated Medical device including unitary, continuous portion of varying durometer
US6527741B1 (en) * 1999-12-21 2003-03-04 Advanced Cardiovascular Systems, Inc. Angioplasty catheter system with adjustable balloon length
US7479128B1 (en) 2000-01-04 2009-01-20 Boston Scientific Scimed, Inc. Protective coatings for medical devices
US6447835B1 (en) * 2000-02-15 2002-09-10 Scimed Life Systems, Inc. Method of coating polymeric tubes used in medical devices
US6561788B1 (en) * 2000-05-31 2003-05-13 Advanced Cardiovascular Systems, Inc. Modular mold designs
US6946174B1 (en) * 2000-10-12 2005-09-20 Boston Scientific Scimed, Inc. Moisture curable balloon materials
US6673302B2 (en) 2001-01-24 2004-01-06 Scimed Life Systems, Inc. Wet processing method for catheter balloons
US6732734B2 (en) 2001-04-27 2004-05-11 Kuraray Co., Ltd. Pilot balloon for balloon catheters
NL1018881C2 (en) * 2001-05-08 2002-11-25 Blue Medical Devices B V Balloon catheter with stent and a method for manufacturing the same.
NL1018018C2 (en) * 2001-05-08 2002-11-19 Blue Medical Devices B V Balloon catheter and method for manufacturing the same.
US6712833B1 (en) 2001-08-22 2004-03-30 Advanced Cardiovascular Systems, Inc. Method of making a catheter balloon
US6946092B1 (en) 2001-09-10 2005-09-20 Scimed Life Systems, Inc. Medical balloon
US20030032963A1 (en) 2001-10-24 2003-02-13 Kyphon Inc. Devices and methods using an expandable body with internal restraint for compressing cancellous bone
US7005097B2 (en) * 2002-01-23 2006-02-28 Boston Scientific Scimed, Inc. Medical devices employing chain extended polymers
US7985234B2 (en) * 2002-02-27 2011-07-26 Boston Scientific Scimed, Inc. Medical device
US7029732B2 (en) * 2002-02-28 2006-04-18 Boston Scientific Scimed, Inc. Medical device balloons with improved strength properties and processes for producing same
US20040138694A1 (en) * 2003-01-15 2004-07-15 Scimed Life Systems, Inc. Intravascular filtering membrane and method of making an embolic protection filter device
WO2004091471A2 (en) * 2003-04-04 2004-10-28 Berger, Constance, F. Apparatus for heating bottles and method of manufacturing same
US9180620B2 (en) * 2003-08-21 2015-11-10 Boston Scientific Scimed, Inc. Medical balloons
US20050124976A1 (en) * 2003-12-04 2005-06-09 Devens Douglas A.Jr. Medical devices
US8620406B2 (en) * 2004-01-23 2013-12-31 Boston Scientific Scimed, Inc. Medical devices visible by magnetic resonance imaging
EP1715990A1 (en) * 2004-02-09 2006-11-02 ContiTech Luftfedersysteme GmbH Vulcanising mould for vehicle tyres
US20050228428A1 (en) * 2004-04-07 2005-10-13 Afsar Ali Balloon catheters and methods for manufacturing balloons for balloon catheters
US7713233B2 (en) * 2004-04-12 2010-05-11 Boston Scientific Scimed, Inc. Balloons having a crosslinkable layer
US8353867B2 (en) * 2004-05-04 2013-01-15 Boston Scientific Scimed, Inc. Medical devices
US20050260355A1 (en) * 2004-05-20 2005-11-24 Jan Weber Medical devices and methods of making the same
US7758572B2 (en) * 2004-05-20 2010-07-20 Boston Scientific Scimed, Inc. Medical devices and methods including cooling balloons having nanotubes
US8043259B2 (en) * 2004-05-24 2011-10-25 Boston Scientific Scimed, Inc. Medical device systems
US7635510B2 (en) * 2004-07-07 2009-12-22 Boston Scientific Scimed, Inc. High performance balloon catheter/component
US7722578B2 (en) * 2004-09-08 2010-05-25 Boston Scientific Scimed, Inc. Medical devices
US8500797B2 (en) * 2004-09-08 2013-08-06 Boston Scientific Scimed, Inc. Medical devices
US8202245B2 (en) * 2005-01-26 2012-06-19 Boston Scientific Scimed, Inc. Medical devices and methods of making the same
US8048028B2 (en) 2005-02-17 2011-11-01 Boston Scientific Scimed, Inc. Reinforced medical balloon
US20060182873A1 (en) * 2005-02-17 2006-08-17 Klisch Leo M Medical devices
US7563400B2 (en) 2005-04-12 2009-07-21 Advanced Cardiovascular Systems, Inc. Method of stent mounting to form a balloon catheter having improved retention of a drug delivery stent
WO2006138741A1 (en) 2005-06-17 2006-12-28 Abbott Laboratories Method of reducing rigidity of angioplasty balloon sections
US7691082B2 (en) * 2005-07-01 2010-04-06 Boston Scientific Scimed, Inc. Medical devices
US7778684B2 (en) * 2005-08-08 2010-08-17 Boston Scientific Scimed, Inc. MRI resonator system with stent implant
US8034066B2 (en) * 2005-09-15 2011-10-11 Boston Scientific Scimed, Inc. Multi-layer medical balloons
US20070085244A1 (en) * 2005-10-17 2007-04-19 Chul Hi Park Method for making inflatable hollow bodies
US7691224B2 (en) * 2005-10-28 2010-04-06 Weller Kip D Thermal bonding method
US20070205539A1 (en) * 2006-03-03 2007-09-06 Boston Scientific Scimed, Inc. Balloon mold design
US20070239256A1 (en) * 2006-03-22 2007-10-11 Jan Weber Medical devices having electrical circuits with multilayer regions
US8858855B2 (en) 2006-04-20 2014-10-14 Boston Scientific Scimed, Inc. High pressure balloon
US7943221B2 (en) * 2006-05-22 2011-05-17 Boston Scientific Scimed, Inc. Hinged compliance fiber braid balloon
US8434487B2 (en) 2006-06-22 2013-05-07 Covidien Lp Endotracheal cuff and technique for using the same
US20070296125A1 (en) * 2006-06-22 2007-12-27 Joel Colburn Thin cuff for use with medical tubing and method and apparatus for making the same
US20080033476A1 (en) * 2006-08-07 2008-02-07 Greene Joel M Catheter balloon with controlled failure sheath
US8609016B2 (en) * 2006-08-28 2013-12-17 Boston Scientific Scimed, Inc. Refoldable balloon and method of making and using the same
US20080053454A1 (en) * 2006-09-01 2008-03-06 Nellcor Puritan Bennett Incorporated Endotracheal tube including a partially inverted cuff collar
US8216267B2 (en) 2006-09-12 2012-07-10 Boston Scientific Scimed, Inc. Multilayer balloon for bifurcated stent delivery and methods of making and using the same
US20080078401A1 (en) * 2006-09-29 2008-04-03 Nellcor Puritan Bennett Incorporated Self-sizing adjustable endotracheal tube
US20080091073A1 (en) * 2006-10-16 2008-04-17 Chul Hi Park Inflatable actuation device
US8088100B2 (en) * 2006-10-20 2012-01-03 Boston Scientific Scimed, Inc. Reinforced rewrappable balloon
US20080275299A1 (en) * 2007-05-01 2008-11-06 Chul Hi Park Actuation device
US8006744B2 (en) * 2007-09-18 2011-08-30 Sturm, Ruger & Company, Inc. Method and system for drying casting molds
US20090131752A1 (en) * 2007-11-19 2009-05-21 Chul Hi Park Inflatable artificial muscle for elongated instrument
US9039748B2 (en) * 2008-04-07 2015-05-26 Abbott Cardiovascular Systems Inc. Method of securing a medical device onto a balloon and system thereof
US20090318863A1 (en) * 2008-06-18 2009-12-24 Boston Scientific Scimed, Inc. Functional Balloon With Built in Lubricity or Drug Delivery System
EP2320985A1 (en) * 2008-07-25 2011-05-18 Cook Incorporated Balloon catheter and method for making the same
DE102008040914A1 (en) * 2008-08-01 2010-02-04 Biotronik Vi Patent Ag A balloon catheter and method for its production
WO2011119536A1 (en) 2010-03-22 2011-09-29 Abbott Cardiovascular Systems Inc. Stent delivery system having a fibrous matrix covering with improved stent retention
US9662677B2 (en) 2010-09-15 2017-05-30 Abbott Laboratories Drug-coated balloon with location-specific plasma treatment
JP5968322B2 (en) * 2010-10-01 2016-08-10 ゼヴェクス・インコーポレーテッド A method for improving accuracy in peristaltic pump systems based on tubing material properties
US8382931B2 (en) * 2011-06-07 2013-02-26 IMEDICOM Co., Ltd. Method of manufacturing a catheter having an expandable member
TWI503346B (en) * 2014-06-11 2015-10-11 Zirco Applied Materials Co Ltd A near infrared light shielding film, and a method of producing the near infrared light shielding
WO2017192870A1 (en) 2016-05-04 2017-11-09 Cardiac Pacemakers, Inc. Electrode designs in implantable defibrillator systems

Citations (63)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2690595A (en) 1951-06-22 1954-10-05 Davol Rubber Co Manufacture of low-pressure inflation catheters
US3457098A (en) 1966-08-18 1969-07-22 Us Health Education & Welfare Nonthrombogenic plastic surfaces and preparation thereof
US3617344A (en) 1966-08-05 1971-11-02 Us Health Education & Welfare Nonthrombogenic plastic surfaces and preparation thereof
US3846353A (en) 1970-06-08 1974-11-05 Department Of Health Education Nonthrombogenic plastic material and method for making the same
US3853804A (en) 1970-08-14 1974-12-10 California Inst Of Techn Ionic block elastomeric polymers
US4002709A (en) 1975-09-25 1977-01-11 Phillips Petroleum Company Controlled air in polyester tube extrusion for clear sealable parison
US4066729A (en) 1969-06-04 1978-01-03 Agfa-Gevaert, N.V. Extrusion method and apparatus
US4145466A (en) 1977-09-02 1979-03-20 Rohm And Haas Company Melt strength improvement of PET
US4232608A (en) 1978-12-04 1980-11-11 Aerojet-General Corporation Dimer isocyanate liner compositions
US4249971A (en) 1979-04-25 1981-02-10 Amerace Corporation Process for making elastomeric hose
US4254774A (en) 1979-02-14 1981-03-10 The United States Of America As Represented By The Department Of Health, Education And Welfare Balloon catheter and technique for the manufacture thereof
US4338942A (en) 1980-10-20 1982-07-13 Fogarty Thomas J Dilatation catherter apparatus
US4387833A (en) 1980-12-16 1983-06-14 Container Industries, Inc. Apparatus for containing and dispensing fluids under pressure and method of producing same
US4403612A (en) 1980-10-20 1983-09-13 Fogarty Thomas J Dilatation method
US4413989A (en) 1980-09-08 1983-11-08 Angiomedics Corporation Expandable occlusion apparatus
US4443399A (en) 1981-05-07 1984-04-17 Idemitsu Petrochemical Co., Ltd. Method of producing biaxially oriented sheet or film and apparatus therefor
GB2130093A (en) 1982-10-14 1984-05-31 Matburn Dilatation catheter
US4456000A (en) 1981-08-17 1984-06-26 Angiomedics Corporation Expandable occlusion apparatus
US4487808A (en) 1982-04-22 1984-12-11 Astra Meditec Aktiebolag Medical article having a hydrophilic coating
US4490421A (en) 1983-07-05 1984-12-25 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US4521564A (en) 1984-02-10 1985-06-04 Warner-Lambert Company Covalent bonded antithrombogenic polyurethane material
US4550007A (en) 1981-11-10 1985-10-29 Mitsubishi Plastics Industries Limited Process for production of a plastic bottle
US4608984A (en) 1980-10-17 1986-09-02 Fogarty Thomas J Self-retracting dilatation catheter
US4646742A (en) 1986-01-27 1987-03-03 Angiomedics Incorporated Angioplasty catheter assembly
EP0274411A2 (en) 1987-01-09 1988-07-13 C.R. Bard, Inc. Thin wall high strength balloon and method of manufacture
US4786556A (en) 1986-03-24 1988-11-22 Becton, Dickinson And Company Polymeric articles having enhanced antithrombogenic activity
US4793350A (en) 1987-01-06 1988-12-27 Advanced Cardiovascular Systems, Inc. Liquid filled low profile dilatation catheter
USRE32983E (en) 1983-07-05 1989-07-11 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
WO1989008473A1 (en) 1988-03-18 1989-09-21 Boston Scientific Corporation Dilatation balloon
US4884573A (en) 1988-03-07 1989-12-05 Leocor, Inc. Very low profile angioplasty balloon catheter with capacity to use steerable, removable guidewire
US4906244A (en) 1988-10-04 1990-03-06 Cordis Corporation Balloons for medical devices and fabrication thereof
US4932956A (en) 1988-05-10 1990-06-12 American Medical Systems, Inc. Prostate balloon dilator
US4938676A (en) 1988-10-04 1990-07-03 Cordis Corporation Apparatus for manufacturing balloons for medical devices
US4941877A (en) 1989-01-26 1990-07-17 Cordis Corporation Balloon catheter
US4950239A (en) 1988-08-09 1990-08-21 Worldwide Medical Plastics Inc. Angioplasty balloons and balloon catheters
US4952357A (en) 1988-08-08 1990-08-28 Scimed Life Systems, Inc. Method of making a polyimide balloon catheter
US4963313A (en) 1987-11-30 1990-10-16 Boston Scientific Corporation Balloon catheter
US4994072A (en) 1988-08-31 1991-02-19 Meadox Medicals, Inc. Dilation catheter
USRE33561E (en) 1983-07-05 1991-03-26 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US5011648A (en) 1989-02-14 1991-04-30 Van Dorn Company System, method and apparatus for hot fill PET container
US5026607A (en) 1989-06-23 1991-06-25 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
US5087394A (en) 1989-11-09 1992-02-11 Scimed Life Systems, Inc. Method for forming an inflatable balloon for use in a catheter
US5087246A (en) 1988-12-29 1992-02-11 C. R. Bard, Inc. Dilation catheter with fluted balloon
US5108415A (en) 1988-10-04 1992-04-28 Cordis Corporation Balloons for medical devices and fabrication thereof
EP0485903A2 (en) 1990-11-10 1992-05-20 Terumo Kabushiki Kaisha Catheter balloon, balloon catheter equipped with the balloon, and method of manufacturing the balloon
WO1992008512A1 (en) 1990-11-09 1992-05-29 Boston Scientific Corporation Balloon for medical catheter
EP0492361A1 (en) 1990-12-21 1992-07-01 Advanced Cardiovascular Systems, Inc. Fixed-wire dilatation catheter with rotatable balloon assembly
US5156612A (en) 1988-10-04 1992-10-20 Cordis Corporation Balloons for medical devices and fabrication thereof
WO1992019440A1 (en) 1991-05-01 1992-11-12 Danforth Biomedical, Inc. Improved balloon catheter of low molecular weight pet
WO1992019316A1 (en) 1991-04-26 1992-11-12 Boston Scientific Corporation Co-extruded medical balloons and catheter using such balloons
US5192296A (en) 1988-08-31 1993-03-09 Meadox Medicals, Inc. Dilatation catheter
US5195970A (en) 1991-04-26 1993-03-23 Gahara William J Collapsible balloon catheters
EP0540858A1 (en) 1991-09-12 1993-05-12 Advanced Cardiovascular Systems, Inc. Inflatable member having elastic expansion with limited range
EP0420488B1 (en) 1989-09-25 1993-07-21 Schneider (Usa) Inc., Multilayer extrusion as process for making angioplasty balloons
EP0553960A1 (en) 1992-01-31 1993-08-04 Advanced Cardiovascular Systems, Inc. Protective membrane for stent-carrying ballon catheter
US5264260A (en) 1991-06-20 1993-11-23 Saab Mark A Dilatation balloon fabricated from low molecular weight polymers
US5272012A (en) 1989-06-23 1993-12-21 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
US5290306A (en) 1989-11-29 1994-03-01 Cordis Corporation Puncture resistant balloon catheter
US5304340A (en) 1991-09-06 1994-04-19 C. R. Bard, Inc. Method of increasing the tensile strength of a dilatation balloon
US5395333A (en) 1993-09-01 1995-03-07 Scimed Life Systems, Inc. Multi-lobed support balloon catheter with perfusion
US5403340A (en) 1992-09-29 1995-04-04 Scimed Lifesystems Inc. Shrinking balloon catheter having nonlinear compliance curve
US5411477A (en) 1990-05-11 1995-05-02 Saab; Mark A. High-strength, thin-walled single piece catheters
US5496276A (en) * 1993-09-20 1996-03-05 Scimed Life Systems, Inc. Catheter balloon with retraction coating

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US32983A (en) * 1861-08-06 Cast-ibon ordnance
US33561A (en) * 1861-10-22 Improvement in valves and valve-motions for steam-engines
FR2264251B1 (en) * 1974-03-12 1976-10-08 Cesa Valentin
US4156466A (en) * 1978-01-20 1979-05-29 Grizzly Corporation Automatic grade and slope control apparatus

Patent Citations (65)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2690595A (en) 1951-06-22 1954-10-05 Davol Rubber Co Manufacture of low-pressure inflation catheters
US3617344A (en) 1966-08-05 1971-11-02 Us Health Education & Welfare Nonthrombogenic plastic surfaces and preparation thereof
US3457098A (en) 1966-08-18 1969-07-22 Us Health Education & Welfare Nonthrombogenic plastic surfaces and preparation thereof
US4066729A (en) 1969-06-04 1978-01-03 Agfa-Gevaert, N.V. Extrusion method and apparatus
US3846353A (en) 1970-06-08 1974-11-05 Department Of Health Education Nonthrombogenic plastic material and method for making the same
US3853804A (en) 1970-08-14 1974-12-10 California Inst Of Techn Ionic block elastomeric polymers
US4002709A (en) 1975-09-25 1977-01-11 Phillips Petroleum Company Controlled air in polyester tube extrusion for clear sealable parison
US4145466A (en) 1977-09-02 1979-03-20 Rohm And Haas Company Melt strength improvement of PET
US4232608A (en) 1978-12-04 1980-11-11 Aerojet-General Corporation Dimer isocyanate liner compositions
US4254774A (en) 1979-02-14 1981-03-10 The United States Of America As Represented By The Department Of Health, Education And Welfare Balloon catheter and technique for the manufacture thereof
US4249971A (en) 1979-04-25 1981-02-10 Amerace Corporation Process for making elastomeric hose
US4413989A (en) 1980-09-08 1983-11-08 Angiomedics Corporation Expandable occlusion apparatus
US4608984A (en) 1980-10-17 1986-09-02 Fogarty Thomas J Self-retracting dilatation catheter
US4338942A (en) 1980-10-20 1982-07-13 Fogarty Thomas J Dilatation catherter apparatus
US4403612A (en) 1980-10-20 1983-09-13 Fogarty Thomas J Dilatation method
US4387833A (en) 1980-12-16 1983-06-14 Container Industries, Inc. Apparatus for containing and dispensing fluids under pressure and method of producing same
US4443399A (en) 1981-05-07 1984-04-17 Idemitsu Petrochemical Co., Ltd. Method of producing biaxially oriented sheet or film and apparatus therefor
US4456000A (en) 1981-08-17 1984-06-26 Angiomedics Corporation Expandable occlusion apparatus
US4550007A (en) 1981-11-10 1985-10-29 Mitsubishi Plastics Industries Limited Process for production of a plastic bottle
US4487808A (en) 1982-04-22 1984-12-11 Astra Meditec Aktiebolag Medical article having a hydrophilic coating
GB2130093A (en) 1982-10-14 1984-05-31 Matburn Dilatation catheter
US4490421A (en) 1983-07-05 1984-12-25 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
USRE33561E (en) 1983-07-05 1991-03-26 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
USRE32983E (en) 1983-07-05 1989-07-11 E. I. Du Pont De Nemours And Company Balloon and manufacture thereof
US4521564A (en) 1984-02-10 1985-06-04 Warner-Lambert Company Covalent bonded antithrombogenic polyurethane material
US4646742A (en) 1986-01-27 1987-03-03 Angiomedics Incorporated Angioplasty catheter assembly
US4786556A (en) 1986-03-24 1988-11-22 Becton, Dickinson And Company Polymeric articles having enhanced antithrombogenic activity
US4793350A (en) 1987-01-06 1988-12-27 Advanced Cardiovascular Systems, Inc. Liquid filled low profile dilatation catheter
EP0274411A2 (en) 1987-01-09 1988-07-13 C.R. Bard, Inc. Thin wall high strength balloon and method of manufacture
US4963313A (en) 1987-11-30 1990-10-16 Boston Scientific Corporation Balloon catheter
EP0318919B1 (en) 1987-11-30 1994-01-19 Boston Scientific Corporation Balloon catheter
US4884573A (en) 1988-03-07 1989-12-05 Leocor, Inc. Very low profile angioplasty balloon catheter with capacity to use steerable, removable guidewire
WO1989008473A1 (en) 1988-03-18 1989-09-21 Boston Scientific Corporation Dilatation balloon
US4932956A (en) 1988-05-10 1990-06-12 American Medical Systems, Inc. Prostate balloon dilator
US4952357A (en) 1988-08-08 1990-08-28 Scimed Life Systems, Inc. Method of making a polyimide balloon catheter
US4950239A (en) 1988-08-09 1990-08-21 Worldwide Medical Plastics Inc. Angioplasty balloons and balloon catheters
US4994072A (en) 1988-08-31 1991-02-19 Meadox Medicals, Inc. Dilation catheter
US5192296A (en) 1988-08-31 1993-03-09 Meadox Medicals, Inc. Dilatation catheter
US4906244A (en) 1988-10-04 1990-03-06 Cordis Corporation Balloons for medical devices and fabrication thereof
US5108415A (en) 1988-10-04 1992-04-28 Cordis Corporation Balloons for medical devices and fabrication thereof
US5156612A (en) 1988-10-04 1992-10-20 Cordis Corporation Balloons for medical devices and fabrication thereof
US4938676A (en) 1988-10-04 1990-07-03 Cordis Corporation Apparatus for manufacturing balloons for medical devices
US5087246A (en) 1988-12-29 1992-02-11 C. R. Bard, Inc. Dilation catheter with fluted balloon
US4941877A (en) 1989-01-26 1990-07-17 Cordis Corporation Balloon catheter
US5011648A (en) 1989-02-14 1991-04-30 Van Dorn Company System, method and apparatus for hot fill PET container
US5272012A (en) 1989-06-23 1993-12-21 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
US5026607A (en) 1989-06-23 1991-06-25 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
EP0420488B1 (en) 1989-09-25 1993-07-21 Schneider (Usa) Inc., Multilayer extrusion as process for making angioplasty balloons
US5087394A (en) 1989-11-09 1992-02-11 Scimed Life Systems, Inc. Method for forming an inflatable balloon for use in a catheter
US5290306A (en) 1989-11-29 1994-03-01 Cordis Corporation Puncture resistant balloon catheter
US5411477A (en) 1990-05-11 1995-05-02 Saab; Mark A. High-strength, thin-walled single piece catheters
WO1992008512A1 (en) 1990-11-09 1992-05-29 Boston Scientific Corporation Balloon for medical catheter
EP0485903A2 (en) 1990-11-10 1992-05-20 Terumo Kabushiki Kaisha Catheter balloon, balloon catheter equipped with the balloon, and method of manufacturing the balloon
EP0492361A1 (en) 1990-12-21 1992-07-01 Advanced Cardiovascular Systems, Inc. Fixed-wire dilatation catheter with rotatable balloon assembly
US5195969A (en) 1991-04-26 1993-03-23 Boston Scientific Corporation Co-extruded medical balloons and catheter using such balloons
WO1992019316A1 (en) 1991-04-26 1992-11-12 Boston Scientific Corporation Co-extruded medical balloons and catheter using such balloons
US5195970A (en) 1991-04-26 1993-03-23 Gahara William J Collapsible balloon catheters
WO1992019440A1 (en) 1991-05-01 1992-11-12 Danforth Biomedical, Inc. Improved balloon catheter of low molecular weight pet
US5264260A (en) 1991-06-20 1993-11-23 Saab Mark A Dilatation balloon fabricated from low molecular weight polymers
US5304340A (en) 1991-09-06 1994-04-19 C. R. Bard, Inc. Method of increasing the tensile strength of a dilatation balloon
EP0540858A1 (en) 1991-09-12 1993-05-12 Advanced Cardiovascular Systems, Inc. Inflatable member having elastic expansion with limited range
EP0553960A1 (en) 1992-01-31 1993-08-04 Advanced Cardiovascular Systems, Inc. Protective membrane for stent-carrying ballon catheter
US5403340A (en) 1992-09-29 1995-04-04 Scimed Lifesystems Inc. Shrinking balloon catheter having nonlinear compliance curve
US5395333A (en) 1993-09-01 1995-03-07 Scimed Life Systems, Inc. Multi-lobed support balloon catheter with perfusion
US5496276A (en) * 1993-09-20 1996-03-05 Scimed Life Systems, Inc. Catheter balloon with retraction coating

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Levy, "Impoved Dilation catheter Balloons," J. Clinical Engineering, 11, pp. 291-296 (1986), Jul. 1986.
Product Brochures:"Mitsubishi Shape Memory Polymer", Undated, "Processing Instructions For Mitsubshi Shape Memory Polymer", (Apr. 1992); Untitled Exerpt pp. 4-12 and 5 pages Tables, Undated, Pertaining to Mitsubshi Shape Memory Polymers.

Cited By (71)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9814865B2 (en) 2000-10-31 2017-11-14 Cook Medical Technologies Llc Coated medical device
US8673387B2 (en) 2000-10-31 2014-03-18 Cook Medical Technologies Llc Coated medical device
US8974522B2 (en) 2000-10-31 2015-03-10 Cook Medical Technologies Llc Coated medical device
US9694162B2 (en) 2000-10-31 2017-07-04 Cook Medical Technologies Llc Coated medical device
US8172793B2 (en) 2000-10-31 2012-05-08 Cook Medical Technologies Llc Coated medical device
US20040036196A1 (en) * 2002-08-20 2004-02-26 Kimberly-Clark Worldwide, Inc. Powder-free nitrile gloves
US20040073165A1 (en) * 2002-10-15 2004-04-15 Scimed Life Systems, Inc. Controlled deployment balloon
US20040073250A1 (en) * 2002-10-15 2004-04-15 Pederson Gary John Catheter balloon with advantageous cone design
US6835189B2 (en) 2002-10-15 2004-12-28 Scimed Life Systems, Inc. Controlled deployment balloon
US20050203563A9 (en) * 2002-10-15 2005-09-15 Pederson Gary J.Jr. Catheter balloon with advantageous cone design
US7226472B2 (en) 2002-10-15 2007-06-05 Boston Scientific Scimed, Inc. Catheter balloon with advantageous cone design
US6863856B1 (en) 2002-12-30 2005-03-08 Advanced Cardiovascular Systems, Inc. Slotted mold for making a catheter balloon
US7314364B2 (en) 2002-12-30 2008-01-01 Advanced Cardiovascular Systems, Inc. Slotted mold for making a balloon catheter
US20050123640A1 (en) * 2002-12-30 2005-06-09 Mahoney Timothy P. Slotted mold for making a balloon catheter
US20040213933A1 (en) * 2003-04-22 2004-10-28 Medtronic Ave, Inc. Low profile dilatation balloon
US7306616B2 (en) 2003-05-05 2007-12-11 Boston Scientific Scimed, Inc. Balloon catheter and method of making same
US8304050B2 (en) 2003-07-10 2012-11-06 Boston Scientific Scimed, Inc. Medical device tubing with discrete orientation regions
US7727442B2 (en) 2003-07-10 2010-06-01 Boston Scientific Scimed, Inc. Medical device tubing with discrete orientation regions
US20100233404A1 (en) * 2003-07-10 2010-09-16 Boston Scientific Scimed, Inc. Medical device tubing with discrete orientation regions
US20050008806A1 (en) * 2003-07-10 2005-01-13 Scott Schewe Medical device tubing with discrete orientation regions
US8025637B2 (en) 2003-07-18 2011-09-27 Boston Scientific Scimed, Inc. Medical balloons and processes for preparing same
US20100320634A1 (en) * 2003-08-18 2010-12-23 Ashish Varma Process for Producing a Hyper-Elastic, High Strength Dilatation Balloon Made From Multi-Block Copolymers
US20090140449A1 (en) * 2003-08-18 2009-06-04 Ashish Varma Process for Producing a Hyper-Elastic, High Strength Dilatation Balloon made from Multi-Block Copolymers
US20050118370A1 (en) * 2003-08-18 2005-06-02 Medtronic Vascular, Inc. Hyper-elastic, high strength dilatation balloon made from multi-block copolymers
US7879270B2 (en) 2003-08-18 2011-02-01 Medtronic, Inc Process for producing a hyper-elastic, high strength dilatation balloon made from multi-block copolymers
US20050098914A1 (en) * 2003-08-18 2005-05-12 Ashish Varma Process for producing a hyper-elastic, high strength dilatation balloon made from multi-block copolymers
US20050127561A1 (en) * 2003-12-16 2005-06-16 Scimed Life Systems, Inc. Method of making expandable-collapsible bodies by temperature gradient expansion molding
US7985063B2 (en) 2003-12-19 2011-07-26 Boston Scientific Scimed, Inc. Molds and related methods and articles
US20070267780A1 (en) * 2003-12-19 2007-11-22 Boston Scientific Scimed, Inc. Molds and related methods and articles
US20050137619A1 (en) * 2003-12-19 2005-06-23 Scott Schewe Molds and related methods and articles
US7264458B2 (en) 2004-01-07 2007-09-04 Boston Scientific Scimed, Inc. Process and apparatus for forming medical device balloons
US7708928B2 (en) 2004-01-07 2010-05-04 Boston Scientific Scimed, Inc. Process for forming medical device balloons
US20090096134A1 (en) * 2004-01-07 2009-04-16 Boston Scientific Scimed, Inc. Process and Apparatus for Forming Medical Device Balloons
US7465164B2 (en) 2004-01-07 2008-12-16 Boston Scientific Scimed, Inc. Apparatus for forming medical device balloons
US20080050462A1 (en) * 2004-01-07 2008-02-28 Boston Scientific Scimed, Inc. Process and Apparatus for Forming Medical Device Balloons
US20050146085A1 (en) * 2004-01-07 2005-07-07 Scimed Life Systems, Inc. Process and apparatus for forming medical device balloons
US7892478B2 (en) 2004-04-19 2011-02-22 Boston Scientific Scimed, Inc. Catheter balloon mold form and molding process
US20050233025A1 (en) * 2004-04-19 2005-10-20 Scimed Life Systems, Inc. Catheter balloon mold form and molding process
US8062024B2 (en) 2004-04-19 2011-11-22 Boston Scientific Scimed, Inc. Catheter balloon mold form and molding process
US20110165284A1 (en) * 2004-04-19 2011-07-07 Boston Scientific Scimed, Inc. Catheter balloon mold form and molding process
US20060129179A1 (en) * 2004-12-13 2006-06-15 Jan Weber Medical devices formed with a sacrificial structure and processes of forming the same
US8070718B2 (en) 2004-12-13 2011-12-06 Boston Scientific Scimed, Inc. Medical devices formed with a sacrificial structure and processes of forming the same
US20060134357A1 (en) * 2004-12-16 2006-06-22 Medtronic Vascular, Inc. Polymer blends for medical balloons
US20070106216A1 (en) * 2005-11-01 2007-05-10 Boston Scientific Scimed, Inc. Composite balloon
US8876763B2 (en) 2005-11-01 2014-11-04 Boston Scientific Scimed, Inc. Composite balloon
US20070142772A1 (en) * 2005-12-16 2007-06-21 Medtronic Vascular, Inc. Dual-Layer Medical Balloon
US8813750B2 (en) 2006-09-29 2014-08-26 Covidien Lp Self-sizing adjustable endotracheal tube
US8413659B2 (en) 2006-09-29 2013-04-09 Covidien Lp Self-sizing adjustable endotracheal tube
US8807136B2 (en) 2006-09-29 2014-08-19 Covidien Lp Self-sizing adjustable endotracheal tube
EP2689789A1 (en) 2008-03-28 2014-01-29 SurModics, Inc. Insertable medical devices having microparticulate-associated elastic substrates and methods for drug delivery
US10058634B2 (en) 2009-04-28 2018-08-28 Surmodics, Inc. Devices and methods for delivery of bioactive agents
US20100272774A1 (en) * 2009-04-28 2010-10-28 Surmodics, Inc. Devices and methods for delivery of bioactive agents
US8590534B2 (en) 2009-06-22 2013-11-26 Covidien Lp Cuff for use with medical tubing and method and apparatus for making the same
WO2011143237A1 (en) 2010-05-10 2011-11-17 Surmodics, Inc. Glycerol ester active agent delivery systems and methods
US8871819B2 (en) 2010-05-10 2014-10-28 Surmodics, Inc. Glycerol ester active agent delivery systems and methods
WO2012003293A1 (en) 2010-06-30 2012-01-05 Surmodics, Inc. Lipid coating for medical devices delivering bioactive agent
US8927000B2 (en) 2010-06-30 2015-01-06 Surmodics, Inc. Lipid coating for medical devices delivering bioactive agent
WO2012096787A1 (en) 2010-12-30 2012-07-19 Surmodics, Inc. Double wall catheter for delivering therapeutic agent
US8668667B2 (en) 2010-12-30 2014-03-11 Surmodics, Inc. Double wall catheter for delivering therapeutic agent
WO2012092421A2 (en) 2010-12-30 2012-07-05 Surmodics, Inc. Composition for intravascular delivery of therapeutic composition
US10213528B2 (en) 2011-05-20 2019-02-26 Surmodics, Inc. Delivery of hydrophobic active agent particles
US9861727B2 (en) 2011-05-20 2018-01-09 Surmodics, Inc. Delivery of hydrophobic active agent particles
US10213529B2 (en) 2011-05-20 2019-02-26 Surmodics, Inc. Delivery of coated hydrophobic active agent particles
US9757497B2 (en) 2011-05-20 2017-09-12 Surmodics, Inc. Delivery of coated hydrophobic active agent particles
US9370647B2 (en) 2011-07-14 2016-06-21 W. L. Gore & Associates, Inc. Expandable medical devices
US9555119B2 (en) 2012-11-05 2017-01-31 Surmodics, Inc. Composition and method for delivery of hydrophobic active agents
US9999675B2 (en) 2012-11-05 2018-06-19 Surmodics, Inc. Composition and method for delivery of hydrophobic active agents
WO2014186729A1 (en) 2013-05-16 2014-11-20 Surmodics, Inc. Compositions and methods for delivery of hydrophobic active agents
WO2016123480A1 (en) 2015-01-29 2016-08-04 Surmodics, Inc. Delivery of hydrophobic active agent particles
WO2018112196A1 (en) 2016-12-16 2018-06-21 Surmodics, Inc. Hydrophobic active agent particle coatings and methods for treatment
WO2018118671A1 (en) 2016-12-20 2018-06-28 Surmodics, Inc. Delivery of hydrophobic active agents from hydrophilic polyether block amide copolymer surfaces

Also Published As

Publication number Publication date
CA2160487A1 (en) 1995-08-24
US20020110657A1 (en) 2002-08-15
WO1995022367A1 (en) 1995-08-24
CA2160487C (en) 2003-09-23
US5714110A (en) 1998-02-03
DE4480681T1 (en) 1996-04-25
DE4480681T0 (en)
DE4480681C2 (en) 2001-09-27
JPH08509156A (en) 1996-10-01
JP3523876B2 (en) 2004-04-26

Similar Documents

Publication Publication Date Title
EP0651666B1 (en) Balloon assembly with separately inflatable sections
US7465483B2 (en) Radially expandable polytetrafluoroethylene
US5403280A (en) Inflatable perfusion catheter
US7553292B2 (en) Device for treating vulnerable plaque
AU749331B2 (en) Stent deploying catheter system and balloon catheter
KR100474784B1 (en) The method of the formed plastic container
EP0669143B1 (en) Variable diameter balloon dilatation catheter
US8979886B2 (en) Medical balloon and method of making the same
US20020183780A1 (en) Stent installation method using balloon catheter having stepped compliance curve
US5344400A (en) Balloon catheters containing molded polyarylenesulfide material
US5358486A (en) Multiple layer high strength balloon for dilatation catheter
AU647203B2 (en) Catheter balloon and balloon catheter equipped with a balloon
US6004289A (en) Multiple layer high strength balloon for dilatation catheter
EP0692276A2 (en) Catheter tube and a method of processing the inner surface of a tube
EP1154808B1 (en) A balloon for medical devices made from polymer blends containing low melting temperature liquid crystal polymers
US5316016A (en) Imaging balloon catheter and methods for use and manufacture
EP1993629B8 (en) New method to make tube-in-tube balloon
CA2514487C (en) Multilayer balloon catheter
US6585926B1 (en) Method of manufacturing a porous balloon
DE60027195T2 (en) Medical balloon device
US5456666A (en) Medical balloon folding into predetermined shapes and method
US6358227B1 (en) Dilatation catheter balloon made from pen based homopolymer or random copolymer
US7452496B2 (en) Medical device
EP1788959B1 (en) Balloon folding design
US6120523A (en) Focalized intraluminal balloons

Legal Events

Date Code Title Description
STCF Information on status: patent grant

Free format text: PATENTED CASE

FPAY Fee payment

Year of fee payment: 4

AS Assignment

Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA

Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868

Effective date: 20050101

Owner name: BOSTON SCIENTIFIC SCIMED, INC.,MINNESOTA

Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868

Effective date: 20050101

FPAY Fee payment

Year of fee payment: 8

FPAY Fee payment

Year of fee payment: 12